Cardiovascular disease is a serious threat to human health, and early risk prediction of major adverse cardiovascular event in people suspected of coronary heart disease can help guide prevention and clinical decisions. Coronary computed tomography (CT) is a useful imaging tool for evaluation of coronary heart disease, and its ability to reflect coronary atherosclerosis shows potential value for risk prediction. In recent years, various new techniques and studies of coronary CT have emerged for risk prediction of major adverse cardiovascular event in people suspected of coronary heart disease. We will review the background and current study advances of using coronary artery calcium score, coronary CT angiography, and artificial intelligence in this field.
Introduction
Current guidelines recommend moderate-intensity lipid lowering
(low-density lipoprotein cholesterol, LDL-C of <2.6 mmol/L or 30%–49%
reduction from the baseline) for patients with intermediate 10-year
atherosclerotic cardiovascular disease (ASCVD) risk. The effects of
intensive lipid lowering (LDL-C of <1.8 mmol/L) on coronary
atherosclerotic plaque phenotype and major adverse cardiovascular events
(MACE) in adults with both non-obstructive coronary artery disease (CAD)
and low to intermediate 10-year ASCVD risk remain uncertain.
Methods and analysis
Intensive Lipid-lowering for Plaque and Major Adverse Cardiovascular
Events in Low to Intermediate 10-year ASCVD Risk Population is a
multicentre, randomised, open-label, blinded endpoint clinical trial.
Inclusion criteria are as follows: (1) patients with the age of 40–75
years within 1 month of coronary CT angiography (CCTA) and coronary
artery calcium score (CACS) evaluation; (2) population with low to
intermediate 10-year ASCVD risk (<20%) and (3) patients with
non-obstructive CAD (stenosis <50%) using CCTA. 2900 patients will be
randomly assigned to the intensive lipid lowering (LDL-C of
<1.8 mmol/L or ≥50% reduction from the baseline) or the
moderate-intensity lipid lowering (LDL-C of<2.6 mmol/L or 30%–49%
reduction from the baseline) group in a 1:1 ratio. The primary endpoint
is MACE (composite of all-cause death, non-fatal MI, non-fatal stroke,
any revascularisation and hospitalisation for angina) within 3 years
after enrolment. The secondary endpoints are changes in coronary total
plaque volume (mm3), plaque burden (%), plaque
composition (mm3, %), high-risk plaque
characteristics detected using CCTA and CACS determined using
CT.
Ethics and dissemination
Ethics committee approval for this study was obtained from the
review boards of Fuwai Hospital (No.2022-1787) and all other study
sites. Written informed consent will be obtained from all participants.
The results of this study will be published in peer-reviewed journals
and reported at international conferences.
Trial registration number
NCT05462262.
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